Sr. Director, Company Sponsored Trials

Role Summary

Sr. Director, Company Sponsored Trials (CSTs), Med Ops & Program Management leads a Center of Excellence focused on delivery of Incyte-supported medical affairs research with quality, scientific rigor, consistency with strategy, and delivery on time, on budget, and according to all applicable policies, SOPs, and best practices. The role may span a broad spectrum of interventional and observational studies, real-world evidence and health economics/outcomes research, collaborative research, and investigator-initiated research. It involves direct contribution and management of others, including contractors or employees, and collaboration with the Ops and Program Management team to achieve USMA goals and drive continuous improvement of activities, processes, and systems.

Responsibilities

• Operational Support Of Research Activities
  • Work with the Head of Medical Operations and Program Management and the USMA team to ensure appropriate conduct and support of research per Incyte policies, SOPs, work instructions, and best practices.
  • Maintain current training matrix of SOPs and Work Instructions for USMA personnel.
  • Support training and management in identifying opportunities for training in research skills, tools, and processes; assist in creating and performing training as assigned.
  • Ensure medical affairs currency and alignment with R&D process updates.
  • Leverage operational expertise to map/adapt R&D processes or create medical affairs processes where R&D methods are not optimal for medical affairs research.

• Oversight Of Incyte Sponsored Research
  • Perform/oversee CRO and vendor management/oversight as appropriate for Incyte.
  • Perform/oversee study startup, execution, maintenance, and close-out within budget and timelines, in accordance with Incyte SOPs.

• Independent Investigator Initiated Research (IIR) Programs As Assigned
  • Partner with IIR team members to ensure concept/protocol reviews, study execution, maintenance, and close-out within budget and timelines and per Incyte policies, SOPs, and work instructions.

• Support Of Project Management (PM) As Assigned
  • Assist Head of Med Ops and PM colleagues in developing plans/objectives; monitor deliverables; assist in timelines, priorities, and metrics.
  • Serve as a member of the USMA Leadership Team (USMALT), providing guidance on operational feasibility, best practices, and resourcing.
  • Support cross-functional communication among MA teams; ensure MA plans are integrated into higher-level planning.
  • Collaborate with MA home office, field teams, cross-departmental colleagues/stakeholders, and external consultants/vendors to ensure timely, high-quality execution of activities and projects.
  • Support Medical Operations and Analytics by developing/monitoring metrics, tools, and reports to understand KPIs; assist with SOP development/maintenance and tool/process optimization.

Qualifications

• Bachelor‚Äôs degree required; advanced degree preferred
• Significant relevant experience required
• Demonstrated expertise with clinical trial operationalization in biopharma, including GCP, SOPs, and tools
• Clinical development study operations experience preferred; Medical Affairs experience preferred but not required
• Interest and ability to understand operating principles of Med Affairs and to support brand-related projects
• Interest in innovation and ability to lead/implement change through influence and tenacity
• Dependable self-starter, able to handle multiple projects; strong organization and problem-solving skills; ability to escalate/manage stakeholders
• Excellent communication and interpersonal skills; ability to navigate a matrixed organization and work with diverse stakeholders

Skills

• Clinical operations and trial management
• Vendor/CRO oversight
• Project management and cross-functional collaboration
• Process mapping and SOP development
• Training and capability development
• Data-driven monitoring of KPIs and performance metrics

Education

• Bachelor‚Äôs degree required
• Advanced degree preferred

Additional Requirements

• Travel requirements not specified in the description; omit if not essential
• Physical demands not specified; omit if not essential